MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	1094-03
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via attached medwatch (b)(4) that stent was difficult to position and suture detachment occurred which required additional intervention.A percuflex ureteral stents was used in the ureter.During the procedure, the nephroureteral catheter was successfully removed over a guidewire and then placed an 11 french peel-away sheath.A 10 french by 26-cm double-j stent was then advanced over the guidewire.After deployment of the stent, it promptly migrated distally with the deformed proximal retention loop "kinking" in the ureter approximately 5-7 cm from the renal pelvis.The external retention "suture" was found to be unassociated/detached from the proximal aspect of the double j stent upon applying tension to it.Extensive attempts to reposition the stent using vascular snares and multiple catheter and guidewire combinations were attempted but were unsuccessful.The stent could not be appropriately engaged at its proximal aspect.Multiple attempts were made at passage of a guidewire into the stent, without success.Therefore, a guidewire was advanced into the urinary bladder and a vascular snare was used to engage the distal aspect of the double-j stent within the urinary bladder.A second 5 french catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway from the skin entry site and the entry site to the renal capsule.Limited attempts were made through the existing minimal incision to dissect down onto the stent remnant for removal.However, it could not be successfully achieved, so the procedure was modified and completed with the stent remnant remaining inside the patient.No further patient complications were reported.

• Brand Name: PERCUFLEX
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16694189
• Report Number: 2124215-2023-14396
• Device Sequence Number: 7454624
• Product Code: FAD
• UDI-Device Identifier: 08714729031857
• UDI-Public: 08714729031857
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: 1094-03
• Device Catalogue Number: 1094-03
• Device Lot Number: 0025746917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White